Randomized Comparative Study Evaluating the Rate of Occurrence of a Lipoatrophy Syndrome in ARVnaive HIV-1 Infected Patients Receiving NRTI-Sparing Antiretroviral Regimen (Hippocampe - ANRS 121)
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 112
- Locations
- 2
- Primary Endpoint
- Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
Study Overview
Brief Summary
The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).
Detailed Description
The study compare the rate of occurrence of lipoatrophy in ARVnaive HIV-1 infected patients receiving either a NRTI-sparing antiretroviral therapy with NRTI and boosted PI,or a standard antiretroviral therapy with 2 NRTI plus PI or NNRTI.
Patients were randomized (2:1:1) to either PI+NNRTI (Gp1) or standard therapy, 2NRTI+ either PI (Gp2) or + NNRTI (Gp3). The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.
Lipoatrophy is evaluated by evolution of subcutaneous fat in the limbs measured by DEXA (Dual Energy X-ray Absorptiometry)and CT-scan of the thighs between baseline and W96.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed HIV-1-infected diagnosis
- •Naive of antiretroviral treatment
- •Plasma viral load (VL) over 5000 copies/ ml
- •CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml
- •Written, informed consent after approval by the local human research ethics committee
Exclusion Criteria
- •Acute opportunistic infection
- •Pregnancy or breast feeding
- •Cytotoxic systemic chemotherapy except for Kaposi sarcoma
- •Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study
- •Polynuclear neutrophils below 750/mm3
- •Hemoglobin below 8 g/dl
- •Platelets below 20 000/mm3
- •Creatinine level over 1.5 (upper normal) UN
- •ASAT, ALAT, bilirubin level over 3 UN
Outcomes
Primary Outcomes
Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
Secondary Outcomes
- Evaluation of clinical safety
- Evaluation of glucidic and lipids metabolic profile
- During the study until 96 weeks
- Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml
- Evolution of viral load
- Evolution of CD4 lymphocytes
- Evaluation of bone toxicity by measurement of bone density
- Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors
- Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors
- Evaluation of lipohypertrophic syndrome
- Evaluation of mitochondrial toxicity
- Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)